The following data is part of a premarket notification filed by Quality Medical Solusions Llc with the FDA for Laminaria 2mm/3mm/4mm/5mm/6mm/7mm/8mm/9mm.
| Device ID | K021012 |
| 510k Number | K021012 |
| Device Name: | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM |
| Classification | Dilator, Cervical, Hygroscopic-laminaria |
| Applicant | QUALITY MEDICAL SOLUSIONS LLC 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour QUALITY MEDICAL SOLUSIONS LLC 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Product Code | HDY |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-06-25 |
| Summary: | summary |